Proposal for a Council Decision renewing the authorisation for continued marketing of products containing, consisting of, or produced from genetically modified maize Bt11 (SYN-BTØ11-1), authorising foods and food ingredients containing or consisting of field maize Bt11 (SYN-BTØ11-1) pursuant to Regulation (EC) No 1829/2003 and repealing Commission Decision 2004/657/EC (Only the French text is authentic) (Text with EEA relevance
Date: 2010-06-04
Institutions: European Commission
Subjects: food safety, foodstuffs legislation, genetically modified organism, health risk, labelling, maize, market approval

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EUROPEAN COMMISSION 

Brussels, 4.6.2010 
COM(2010)298 final 

2010/0156 (NLE) 

Proposal for a  

COUNCIL DECISION 

renewing the authorisation for continued marketing of products containing, consisting 
of, or produced from genetically modified maize Bt11 (SYN-BTØ11-1), authorising 
foods and food ingredients containing or consisting of field maize Bt11 (SYN-BTØ11-1) 
pursuant to Regulation (EC) No 1829/2003 and repealing Commission Decision 
2004/657/EC 

(Only the French text is authentic) 
(Text with EEA relevance

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EXPLANATORY MEMORANDUM 

The  attached  proposal  for  a  Council  Decision  concerns  the  renewal  of  the  authorisation  for 
continued  marketing  of  existing  foods  and  food  ingredients  produced  from  genetically 
modified  maize  Bt11,  the  renewal  of  the  authorisation  for  continued  marketing  of  existing 
feed containing, consisting of or produced from Bt11 maize and products other that food and 
feed  containing  or  consisting  of  Bt11  maize  with  the  exception  of  cultivation,  for  which  a 
request was submitted by Syngenta Seeds S.A.S. to the Commission on 17 April 2007, under 
Regulation (EC) No 1829/2003 on genetically modified food and feed.  

The attached proposal also concerns the renewal of the authorisation for placing on the market 
of  foods  and  food  ingredients  containing  or  consisting  of  sweet  maize  Bt11  which  are 
authorised under Commission Decision 2004/657/EC and the authorisation of foods and food 
ingredients containing or consisting of field maize which were never authorised in the EU. 

On  17  February  2009,  the  European  Food  Safety  Authority  gave  a  favourable  opinion  in 
accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It considered that Bt11 
maize is as safe as its non-genetically modified counterpart with respect to potential effects on 
human and animal health or the environment. Therefore it concluded that it is unlikely that the 
placing on the market of the products containing, consisting of, or produced from Bt11 maize 
as described in the application will have any adverse effects on human or animal health or the 
environment in the context of their intended uses. 

Against  this  background,  a  draft  Commission  Decision  renewing  the  authorisation  for 
continued  marketing  of  products  containing,  consisting  of  or  produced  from  genetically 
modified Bt11 maize, authorising foods and food ingredients containing or consisting of field 
maize Bt11 and repealing Commission Decision 2004/657/EC was submitted to the Standing 
Committee on the Food Chain and Animal Health, on 19 April 2010, for vote. The Committee 
delivered  no  opinion:  12 Member  States  (167  votes)  voted  in  favour,  9  Member  States 
(84 votes)  voted  against,  3 Member  States  (46 votes)  abstained  and  3  Member  States 
(48 votes) were not represented. 

Consequently, pursuant to Article 35, paragraph 2 of Regulation (EC) No 1829/2003 and in 
accordance  with  Article  5  of  Council  Decision  1999/468/EC  modified  by  Council  Decision 
2006/512/EC, the Commission is required to submit to the Council a proposal relating to the 
measures to be taken, the Council having three months in which to act by a qualified majority, 
and inform the Parliament. 

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2010/0156 (NLE) 

Proposal for a 

COUNCIL DECISION 

renewing the authorisation for continued marketing of products containing, consisting 
of, or produced from genetically modified maize Bt11 (SYN-BTØ11-1), authorising 
foods and food ingredients containing or consisting of field maize Bt11 (SYN-BTØ11-1) 
pursuant to Regulation (EC) No 1829/2003 and repealing Commission Decision 
2004/657/EC 

(Only the French text is authentic) 
(Text with EEA relevance) 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty on the Functioning of the European Union, 

Having  regard  to  Regulation  (EC)  No  1829/2003  of  the  European  Parliament  and  of  the 
Council  of  22  September  2003  on  genetically  modified  food  and  feed1,  and  in  particular 
Articles 7(3), 11(3), 19(3) and 23(3) thereof, 

Having regard to the proposal from the European Commission, 

Whereas: 

(1) 

On 17 April 2007, Syngenta Seeds S.A.S. on behalf of Syngenta Crop Protection AG, 
submitted to the Commission an application, in accordance with Articles 5, 11, 17 and 
23 of Regulation  (EC) No 1829/2003,  for renewal of the authorisation for continued 
marketing  of  existing  foods  and  food  ingredients  produced  from  Bt11  maize 
(including food additives), and renewal of the authorisation for continued marketing of 
existing  feed  containing,  consisting  of  or  produced  from  Bt11  maize  (including  feed 
additives  and  feed  materials)  and  products  other  than  food  and  feed  containing  and 
consisting  of  Bt11  maize  with  the  exception  of  cultivation  ('the  application')  which 
were previously notified in accordance with Article 8(1)(a)(b) and Article 20(1)(a)(b) 
of that Regulation. The application also covers the renewal of the authorisation for the 
placing  on  the  market  of  foods  and  food  ingredients  which  are  authorised  under 
Commission  Decision  2004/657/EC  of  19  May  2004  authorising  the  placing  on  the 
market  of  sweet  corn  from  genetically  modified  maize  line  Bt11  as  a  novel  food  or 
novel food ingredients under Regulation (EC) No 258/97 of the European Parliament 
and of the Council2. Within its application, Syngenta Seeds SA.S. also requested the 
authorisation  of  foods  and  food  ingredients  containing  or  consisting  of  Bt11  field 
maize which were never authorised in the Union. 

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2 

OJ L 268, 18.10.2003, p. 1. 
OJ L 300, 25.9.2004, p. 48. 

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(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

On  17  February  2009,  the  European  Food  Safety  Authority  ('EFSA’)  gave  a 
favourable  opinion3  in  accordance  with  Articles  6  and  18  of  Regulation  (EC) 
No 1829/2003 and concluded that the new information provided in the application and 
the  review  of  the  literature  that  has  been  published  since  the  previous  scientific 
opinion on Bt11 maize4 by EFSA does not require changes and confirmed the previous 
conclusion that Bt11 maize is as safe as its non-genetically modified counterpart and 
that  it  is  unlikely  to  have  an  adverse  effect  on  human  and  animal  health  or  the 
environment  in  the  context  of  its  proposed  uses  which  also  applies  to  the  products 
which are subject of the application. 

In its opinion, EFSA considered all the specific questions and concerns raised by the 
Member States in the context of the consultation of the national competent authorities 
as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003. 

In  its  opinion,  EFSA  also  concluded  that  the  environmental  monitoring  plan, 
consisting of a general surveillance plan, submitted by the applicant is in line with the 
intended use of the products. 

Taking  into  account  these  considerations,  the  fact  that  the  company  Syngenta  Crop 
Protection  AG  Switzerland  which  absorbed  Syngenta  Seeds  AG,  addressee  of 
Decision 2004/657/EC is the same legal entity, on behalf of which the applicant asked 
for the renewal of authorisation, that it confirmed that the scope of its application also 
covers  the  request  for  authorisation  of  foods  and  food  ingredients  containing  or 
consisting  of  Bt11  field  maize  and  that  it  intended  to  ask  for  a  renewal  of  products 
covered  by  Decision  2004/657/EC  prior  to  the  expiration  of  the  authorisation 
mentioned in that Decision so that a single Decision covering these products may be 
adopted  which  will  take  effect  on  the  same  date,  renewal  of  the  authorisation  for 
continued  marketing  of  the  existing  products,  renewal  of  the  authorisation  of  foods 
and  food  ingredients  containing,  consisting  of  or  produced  from  Bt11  sweet  maize 
(sweet  maize  fresh  or  canned)  and  authorisation  of  food  and  foods  ingredients 
containing  or  consisting  of  Bt11  field  maize  should  be  granted.  Consequently, 
Commission Decision 2004/657/EC should be repealed. 

A unique identifier should be assigned to each GMO as provided for in Commission 
Regulation  (EC)  No  65/2004  of  14  January  2004  establishing  a  system  for  the 
development and assignment of unique identifiers for genetically modified organisms5. 

On the basis of the EFSA opinion, no specific labelling requirements other than those 
provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to 
be  necessary  for  foods,  food  ingredients  and  feed  containing,  consisting  of,  or 
produced from Bt11 maize. However, in order to ensure the use of the products within 
the  limits  of  the  authorisation  provided  for  by  this  Decision,  the  labelling  of  feed 
containing or consisting of the GMO and products other than food and feed containing 
or consisting of the GMO for which renewal of the authorisation is requested should 
be complemented by a clear indication that the products in question must not be used 

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http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2007-146 
EFSA opinion published on 19 May 2005, for the placing on the market of Bt11 for cultivation, feed 
and industrial processing – 
http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2004-12 
OJ L 10, 16.1.2004, p. 5. 

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for  cultivation.  The  authorisation  holder  should  submit  annual  reports  on  the 
implementation  and  the  results  of  the  activities  set  out  in  the  monitoring  plan  for 
environmental  effects.  Those  results  should  be  presented  in  accordance  with 
Commission  Decision  2009/770/EC  of  13  October  2009  establishing  standard 
reporting  formats  for  presenting  the  monitoring  results  of  the  deliberate  release  into 
the environment of genetically modified organisms, as or in products, for the purpose 
of  placing  on  the  market,  pursuant  to  Directive  2001/18/EC  of  the  European 
Parliament and of the Council6. 

(8) 

Similarly, the EFSA opinion does not justify the imposition of specific conditions or 
restrictions for the placing on the market and/or specific conditions or restrictions for 
the use and handling, including post-market monitoring requirements for the use of the 
the  protection  of  particular 
food  and  feed,  or  of  specific  conditions  for 
ecosystems/environment  and/or  geographical  areas,  as  provided  for  in  point  (e)  of 
Articles 6(5) and 18(5) of Regulation (EC) No 1829/2003. 

(9) 

All relevant information on the authorisation or the renewal of the products should be 
entered in the Community register of genetically modified food and feed, as provided 
for in Regulation (EC) No 1829/2003. 

(10)  Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the 
Council of 22 September 2003 concerning the traceability and labelling of genetically 
modified  organisms  and  the  traceability  of  food  and  feed  products  produced  from 
genetically  modified  organisms  and  amending  Directive  2001/18/EC7,  lays  down 
labelling requirements for products consisting of, or containing GMOs. 

(11)  This Decision is to be notified through the Biosafety Clearing-House to the Parties to 
the  Cartagena  Protocol  on  Biosafety  to  the  Convention  on  Biological  Diversity, 
pursuant to Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the 
European Parliament and of the Council of 15 July 2003 on transboundary movements 
of genetically modified organisms8. 

(12)  The applicant has been consulted on the measures provided for in this Decision. 

(13)  The Standing Committee on the Food Chain and Animal Health has not delivered an 

opinion within the time-limit laid down by its Chairman, 

HAS ADOPTED THIS DECISION: 

Article 1 
Genetically modified organism and unique identifier 

Genetically modified maize Bt11 (Zea mays L.), as specified in point (b) of the Annex to this 
Decision, is assigned the unique identifier SYN-BTØ11-1, as provided for in Regulation (EC) 
No 65/2004. 

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8 

OJ L 275, 21.10.2009, p. 9. 
OJ L 268, 18.10.2003, p. 24. 
OJ L 287, 5.11.2003, p. 1. 

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Article 2 
Authorisation  

The  following  products  are  authorised  for  the  purposes  of  Articles  4(2)  and  16(2)  of 
Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision: 

(a) 

(b) 

(c) 

1. 

2. 

1. 

2. 

foods and food ingredients containing, consisting of or produced from SYN-BTØ11-
1 maize; 

feed containing, consisting of, or produced from SYN-BTØ11-1 maize; 

products other than food and feed containing or consisting of SYN-BTØ11-1 maize 
for the same uses as any other maize with the exception of cultivation. 

Article 3 
Labelling 

For  the  purposes  of  the  labelling  requirements  laid  down  in  Article  13(1)  and 
Article 25(2)  of  Regulation  (EC)  No  1829/2003  and  in  Article  4(6)  of  Regulation 
(EC) No 1830/2003, the ’name of the organism’ shall be ’maize’. 

The  words  'not  for  cultivation'  shall  appear  on  the  label  of  and  in  documents 
accompanying products containing or consisting of SYN-BTØ11-1 maize referred to 
in Article 2(b) and (c). 

Article 4 
Monitoring for environmental effects 

The  authorisation  holder  shall  ensure  that  the  monitoring  plan  for  environmental 
effects, as set out in point (h) of the Annex, is put in place and implemented. 

The  authorisation  holder  shall  submit  to  the  Commission  annual  reports  on  the 
implementation  and  the  results  of  the  activities  set  out  in  the  monitoring  plan  in 
accordance with Decision 2009/770/EC. 

Article 5 
Community register 

The  information  set  out  in  the  Annex  to  this  Decision  shall  be  entered  in  the  Community 
register  of  genetically  modified  food  and  feed,  as  provided  for  in  Article  28  of  Regulation 
(EC) No 1829/2003. 

Article 6 
Authorisation holder 

The authorisation holder shall be Syngenta Seeds S.A.S., France, representing Syngenta Crop 
Protection AG, Switzerland. 

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This Decision shall apply for a period of 10 years from the date of its notification. 

Article 7 
Validity 

Commission Decision 2004/657/EC is repealed. 

Article 8 
Repeal 

Article 9 
Addressee 

This Decision is addressed to Syngenta Seeds S.A.S., Chemin de l'Hobit 12, BP 27 – F-31790 
Saint-Sauveur – France representing Syngenta Crop Protection AG, Switzerland. 

Done at Brussels, 

For the Council 
The President 

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ANNEX 

(a) 

Applicant and Authorisation holder: 

Name: 

Syngenta Seeds S.A.S. 

Address: 

Chemin de l'Hobit 12, BP 27 – F-31790 Saint-Sauveur – France 

On behalf of Syngenta Crop Protection AG - Schwarzwaldallee 215 - CH 4058 Basle 
- Switzerland  

(b) 

Designation and specification of the products: 

(1)  Foods and food ingredients containing, consisting of, or produced from SYN-

BTØ11-1 maize; 

(2)  Feed containing, consisting of, or produced from SYN-BTØ11-1 maize; 

(3)  Products  other  than  food  and  feed  containing  or consisting of SYN-BTØ11-1 

maize for the same uses as any other maize with the exception of cultivation. 

The  genetically  modified  SYN-BTØ11-1  maize,  as  described  in  the  application, 
expresses the Cry1Ab protein which  confers  protection against certain  lepidopteran 
pests  and  the  PAT  protein  which  confers  tolerance  to  the  glufosinate-ammonium 
herbicide. 

(c) 

Labelling: 

(1)  For  the  purposes  of  the  specific  labelling  requirements  laid  down  in  Articles 
13(1)  and  25(2)  of  Regulation  (EC)  No  1829/2003,  and  in  Article  4(6)  of 
Regulation (EC) No 1830/2003, the ’name of the organism’ shall be ’maize’. 

(2)  The  words  'not  for  cultivation'  shall  appear  on  the  label  of  and  in  documents 
accompanying  products  containing  or  consisting  of  SYN-BTØ11-1  maize 
referred to in Article 2(b) and (c). 

(d) 

Method for detection: 

– 

– 

– 

Event  specific  real-time  PCR  based  method  for  the  quantification  of  SYN-
BTØ11-1 maize 

the  Community  Reference  Laboratory  established  under 
Validated  by 
http://gmo-
(EC) 
Regulation 
crl.jrc.ec.europa.eu/statusofdoss.htm 

1829/2003, 

published 

No 

at 

Reference  Material:  ERM®-BF412  accessible  via  the  Joint  Research  Centre 
(JRC)  of  the  European  Commission,  Institute  for  Reference  Materials  and 
Measurements (IRMM) at https://irmm.jrc.ec.europa.eu/rmcatalogue 

(e) 

Unique identifier: 

SYN-BTØ11-1 

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(f) 

Information required under Annex II to the Cartagena Protocol on Biosafety to 
the Convention on Biological Diversity: 

Biosafety Clearing-House, Record ID: see [to be completed when notified] 

(g) 

Conditions or restrictions on the placing on the market, use or handling of the 
products: 

Not required. 

(h) 

Monitoring plan 

Monitoring plan for environmental effects conforming with Annex VII to Directive 
2001/18/EC 

[Link: plan published on the internet] 

(i) 

Post  market  monitoring  requirements  for  the  use  of  the  food  for  human 
consumption 

Not required. 

Note: links to relevant documents may need to be modified over the time. Those modifications 
will be made available to the public via the updating of the Community register of genetically 
modified food and feed. 

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